The IOM Weighs In on Health IT Safety

But the push [to adopt electronic health records] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.

“With all of that money, marketing and public outreach, most simply affirm the value of health IT as an article of faith, rather than investigate it via careful evaluation,” said Ross Koppel, adjunct professor of sociology at the University of Pennsylvania and its School of Medicine, and investigator for RAND Corporation. He is listed as one of the reviewers of the report.

I've read Ross Koppel's work, and seen him speak, and firmly believe he's a brilliant guy. But I disagree that we're accepting health IT's value on faith, because of marketing. We've seen IT transform the way we do business in every other sphere of American life, and many of us have experienced the benefits of easily retrieved patient records and clear, electronic communication between providers. As I've said before -- aside from a few train-wreck implementations, who would go back to paper records, if given the chance? Who would build a new hospital based on anything but an electronic system?

The IOM isn't saying paper's better, but they do recommend caution with, and further study of, health IT:

...In its report, the IOM committee says the FDA would likely restrict market innovation in health IT, which could also jeopardize patient safety. Stringent regulations “can negatively impact the development of new technology by limiting implementation choices and restricting manufacturers’ flexibility to address complex issues,” the report says. The FDA currently receives voluntary reports of health IT-related incidents, but has no resources or protocols through which to take action; the agency has long fought a losing battle with health IT vendors over trying to monitor the technology.

The report also notes the agency does not have the investigative capabilities, funding or manpower to regulate devices such as electronic health records, personal health records or health information exchanges.

...To adequately oversee health IT safety, the committee recommends that the secretary of health and human services create and fund a new independent watchdog agency, along the lines of the National Transportation Safety Board. Like NTSB, the new agency would conduct investigations and make recommendations for all stakeholders, including the secretary of the health and human services, vendors and health care organizations. Vendors of the technology would be required to report adverse events, while reporting would be voluntary for clinicians. Like NTSB, though, the new agency would also have no enforcement power.

I'm all for reporting safety issues, near-misses and other risks of health IT. I think the vendors have really done themselves a disservice here by insisting on gag rules among their hospital clients -- doctors would be in violation of their contracts if they posted a screenshot of their EHR software online, let alone spoke publicly about some clunky or possibly dangerous glitches.

And I kind of like the idea of an NTSB-like agency, swooping in after a prescription error or lost bed assignment. Certainly, that model seems preferable to an FDA oversight, which might require extensive pre-implementation testing (beyond the current certification process) and I think would tend to slow down the pace of innovation and lock-in the clunky, slow interfaces doctors have come to expect from EHR.

But I have to ask: what country, what era, has the IOM been living in? Because expecting the creation of a new regulatory agency in the US in 2011, with an obstructionist Congress that's breaking filibuster records just to spite the administration, is a pipe dream.

And if no new regulatory agency is forthcoming, where does that leave the federal incentives for adoption and meaningful use of electronic health records? Already, the effort is stalled and seems likely be dragged out over an additional period. Now critics of MU will point to this phantom Health IT safety board, which ought to exist but probably won't, as a further excuse to delay, delay, delay. The status quo is cheaper. It's familiar. And so we'll keep handwriting notes and shooting paper orders through pneumatic tubes, in the name of patient safety.

The iWatch kicker:

In its report, the IOM panel also recommended that more studies be conducted to quantify health IT-related deaths, serious injuries or unsafe conditions so that the safety concerns can be properly addressed. “You can only improve what you measure,” says the report.

So true! And what we have in place now, across the majority of US hospitals, is patient care managed with clipboards and three-ring binders, full of handwritten notes and orders. Can those be measured in a systematic way (you know, for the sake of improvement)? Of course not.

It seems like health IT is a victim of its own capabilities. Because technology lets us measure and record how we practice, it is scrutinized to a far greater extent than the antiquated system it aims to replace. Because we can't begin to calculate how dangerous the status quo paper-and-clipboard system is, we'll end up keeping it, longer than any other US industry.